Vaisala has added several new webinars to its popular series, including ‘Mean Kinetic Temperature in GxP Environments.’
All upcoming and recoded webinars are available on their website.
In one of the webinars, Vaisala outlines the history of the mean kinetic temperature calculation in pharmaceutical manufacturing and distribution.
The company also discusses regulatory guidance that describes where and when it is appropriate to use the mean kinetic temperature calculation, including FDA, EMA, and ICH.
Vaisala senior regulatory expert Paul Daniel will provide six clear recommendations for using the calculation, including where it is useful in decision-making for regulated industries, and where it is not.
Participants will learn about MKT as a non-linear weighted average that shows the effects of temperature variations over time.
For example, if participants understand why MKT was originally used to select temperatures for long-term stability studies, they understand why MKT is suitable for evaluating the long-term temperature performance of ambient storage areas.
Webinar participants can ask about best practices for the MKT calculation in their controlled environments and will become familiar enough with the value to be able to use it to interpret their own data, and explain their decisions to an auditor.
The seminars are taught by Paul Daniel.
For more information, please visit the company’s website.